Intragastric balloon retrieval mechanisms

ABSTRACT

A mechanism for removing a fluid-filled object from a patient. The apparatus includes a deflation tube with a puncture member at one end of the tube for piercing a hole in the object wall. The apparatus includes a retrieval mechanism slidable within the deflation tube lumen. The retrieval mechanism includes an expansion element that is expandable when positioned within the object from a first configuration with a dimension less than that of the deflation tube lumen to a second or deployed configuration with a dimension that is greater than an outer dimension of the puncture member. The expansion element contacts an inner surface of the inflatable object as the deflation tube and retrieval mechanism are withdrawn from the body cavity. The expansion element may be a T-bar, a foldable anchor, an inflatable member, or another expandable form.

RELATED APPLICATION

This is a divisional of U.S. patent application Ser. No. 11/450,665,filed on Jun. 9, 2006, the entire disclosure of which is incorporatedherein by this specific reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates, in general, to the use of an intragastricballoon and similar fluid-filled objects in treating obesity, and moreparticularly, to the devices and systems for endoscopical deflating andremoving or retrieving such intragastric balloons and/or otherfluid-filled objects from the stomachs of patients.

2. Relevant Background

Intragastric balloons, such as that described in U.S. Pat. No. 5,084,061or other balloons and objects commercially available, are designed forproviding short-term therapy for moderately obese individuals who needto shed pounds in preparation for surgery or as part of a dietary andbehavioral modification program. A challenge with such balloons orfluid-filled objects is their removal after completion of therapy.

A typical intragastric balloon is a made of a silicone elastomer shellthat is inserted into the stomach of a patient and then filled withfluid. For example, commercially available intragastric balloons arefilled with saline solution or air but other fluids may be used in somesituations. The intragastric balloon functions by partially filling thestomach, which enhances appetite control. Placement and filling of theintragastric balloon is completed non-surgically with a surgeon ordoctor using an endoscope, gastroscope, or other device that is adaptedfor viewing internal cavities of a patient and with lumen or hollowchannels for passing the retrieval instruments. Placement ofintragastric balloons is temporary, and intragastric balloons aretypically removed after six to twelve months.

Historically, endoscopic deflation and extraction of intragastricballoons has been an arduous task due to the difficulty associated withmanipulating the balloon within the stomach. One method of removing theballoon involves several steps, each with its own tool. A sharp-endedpuncture device, sometimes called a “killer,” is inserted through theworking channel of an endoscope to puncture the balloon. The puncturedevice is then removed, and the saline solution is either allowed toenter the stomach cavity, or removed via an aspiration tube insertedthrough the working channel and into the balloon. Finally, a graspingdevice or “grasper” having prongs, teeth, or a wire loop is insertedthrough the working channel to snag or snare the outside surfaces of theballoon. Once the outside of the balloon is hooked or grasped, thegrasping device is used to pull the balloon through the esophagus as thegastroscope is removed. Other tools have been developed that provide asingle tool that can pierce the balloon's shell, evacuate the fluid todeflate the balloon, and grasp or hook the outer surfaces of theballoon.

Even with these efforts, the retrieval of untethered intragastricballoons or other fluid-filled objects from a patient's stomachcontinues to present problems and can be a difficult task. The outersurface of the balloons is coated with gastric fluids in the stomach andtends to be very slippery or slick, which makes it difficult for even arelatively sharp grasper tool to grasp the balloon. One technique foraddressing this issue is described in U.S. Pat. No. 5,084,061 andincludes providing a retrieval tab on the outer surface of the balloon.A tool with a hook, loop, or snare then has to be latched onto the tabto allow retrieval. This technique has not been widely adopted as itrequires specially manufactured balloons or objects with the externaltab and also requires that the balloon be manipulated within thepatient's stomach to find and align the tab with the hook on the removaltool, and this is often difficult to perform endoscopically (e.g., withlimited tool dexterity and in limited visibility and light provided bythe endoscope).

Therefore, it is desirable to provide an endoscopic device for removingan intragastric balloon in which the above mentioned disadvantages aresubstantially overcome.

Hence, there remains a need for an improved tool for supportingdeflation and retrieval of intragastric balloons and other fluid-filledobjects from the stomach of patients. Preferably, such a tool would beuseful with existing medical systems or tools such as endoscopes andwould provide quicker and more effective grasping or capture of theballoon or object to better support out-patient procedures.

SUMMARY OF THE INVENTION

The present invention addresses the above problems by providing a systemand method for removing fluid-filled objects, such as intragastricballoons, from a body cavity of a patient. In contrast to prior devicesthat grasp the outer surfaces of an object, the removal system of thepresent invention includes a retrieval mechanism that can be insertedwithin the object via a lumen of the device used to deflate or aspiratethe object contents (e.g., an aspirator tube or the like). The retrievalmechanism includes an expansion element that can be compressed orprovided in a first configuration that allows it to readily pass throughthe deflation tube lumen but that expands to a second or deployedconfiguration when it is positioned within the unrestricted space withinthe interior of deflated object to be removed. The second or deployedconfiguration of the expansion element is typically significantly largerthan the outer dimensions of the deflation tube, and as a result,surfaces of the expansion element contact the inner surfaces of theobject when the retrieval mechanism is withdrawn from the body cavity,thereby capturing and removing the object. The expansion element maytake numerous forms, as discussed in detail herein, such as, but notlimited to, a T-bar, a foldable anchor, an inflatable member, a springretriever, an elongate body with tabbed ends, an expandable tubularbody, and a rollable or collapsible cone.

More particularly, an apparatus is provided for removing an inflatableobject from a body cavity of a patient. The apparatus includes anaspiration or deflation tube with a lumen and a puncture member, such asa hollow needle, at one end of the tube for piercing a hole in the wallof the inflatable object. The puncture member includes a lumen that isin fluid communication or is fluidly coupled with the deflation tubelumen. The apparatus further includes a retrieval mechanism that can beslid within the deflation tube lumen. Significantly, the retrievalmechanism includes an expansion element that is expandable whenpositioned within the inflatable object from a first configuration witha dimension less than that of the deflation tube lumen to a second ordeployed configuration with a dimension measured transverse to thedeflation tube lumen that is greater than an outer dimension of thepuncture member. In this second or deployed configuration, the expansionelement has at least one contact surface (e.g., a surface extendingtransverse to an axis of the puncture member lumen) that contacts aninner surface of the inflatable object proximate to the hole formed inthe wall of the inflatable object as the deflation tube and retrievalmechanism are withdrawn from the body cavity.

According to another aspect of the invention, a method is provided forevacuating and removing a fluid-filled object positioned in a bodycavity. The method includes positioning an aspirator device in the bodycavity and piercing a wall of the fluid-filled object with the aspiratordevice that includes a tube with a lumen, e.g., the piercing results ina portion of the tube passing through the shell wall and providingaccess to the interior of the object via the lumen. The method continueswith advancing a retrieval mechanism into the lumen of the aspiratortube. The retrieval mechanism includes an expansion element that has adeployed configuration that is greater in size than the outer diameterof the aspirator tube, and the advancing includes extending theexpansion element at least partially out of the lumen and into thepierced object. The expansion element then expands to its deployedconfiguration, and then the retrieval mechanism is withdrawn along withthe aspirator device, which results in the expansion element contactingan inner surface of the object wall to cause the object to be removedfrom the body cavity along with the retrieval mechanism.

The retrieval mechanism typically also includes a flexible deploymentmember (such as a wire, wire rope, flexible tube, or the like) that isattached to the expansion element. The expansion element may take anumber of forms, and for example, it may be selected from: a T-bar, anobject inflated during the expanding of the expansion element, a foldinganchor device that unfolds to the deployed configuration, a springelement that returns to an at-rest position during the expanding of theexpansion element, an elongate body with tabs attached at opposite ends,a tubular body with slits cut in a spaced-apart manner, parallel to alongitudinal axis of the tubular body and with a tensioning wireattached to an end of tubular body, and a funnel collapsible into acylinder and expandable into a frustaconical shape in the deployedconfiguration.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a partial cutaway view of an inflatable objectretrieval system according to one embodiment that is useful fordeflating and removing a fluid-filled object such as an intragastricballoon from the stomach or other cavity of a patient;

FIGS. 2A-2C illustrate in more detail the “T-bar” retrieval mechanismshown in the system of FIG. 1 as it is being used to grasp and remove anobject after deflation;

FIGS. 3A-3C illustrate similarly to FIGS. 2A-2C a retrieval mechanismaccording to the invention in which the expansion or grasper portion orelement itself is inflatable and may be used in object retrieval systemssuch as that shown in FIG. 1;

FIGS. 4A and 4B is another retrieval mechanism according to theinvention that may be used with the system shown in FIG. 1 and thatutilizes a “folding anchor” type of expansion or grasper element;

FIGS. 5A and 5B is yet another retrieval mechanism that may be used withthe system of FIG. 1 and that includes an expansion or grasper elementthat is made up of a spring member that uncoils to its at restconfiguration within the retrieved object;

FIGS. 6A and 6B illustrate a retrieval mechanism with an expansion orgrasper element similar to that shown in FIGS. 2A-2C that utilizes aplurality of tabs to engage the inner surface of an object beingretrieved;

FIGS. 7A and 7B illustrates still another retrieval mechanism usefulwith the retrieval systems of the invention that includes yet anotherembodiment of an expansion or grasper element (e.g., an expandable tubetip) useful for grasping or engaging inner surfaces of a balloon orother inflatable/deflatable object; and

FIGS. 8A-8D illustrates a retrieval mechanism with a funnel-basedexpansion or grasper element.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is directed to methods and systems for retrievingfluid-filled objects from stomachs or other cavities of patients. Thefollowing description describes particularly systems and theiroperations for deflating, engaging or grasping, and retrieving orremoving intrastric balloons from the stomach of a patient, but theconcepts are equally applicable to nearly any object or hollow shapethat is inflatable with fluid. Intragastric balloon retrieval systems ofthe invention are described as being useful with standard endoscopes,gastroscopes or the like that include a working channel through whichthe retrieval system can be passed to a stomach of a patient. Further,in a typical embodiment, the retrieval systems include a device forpuncturing the shell of the intragastric balloon and for inserting anend of a tube, or an outlet of a lumen in such tube, within theintragastric balloon. The lumen can be used to deflate or aspirate thecontents of the balloon. Then, during balloon retrieval procedures, aretrieval mechanism of the invention is inserted through the lumen (oris passed further through the lumen in embodiments in which themechanism remains in the lumen during deflation).

Significantly, each embodiment of the retrieval mechanisms of theinvention includes an expansion or grasping element at or proximal toits distal end that is inserted through the lumen of the deflation tubeso as to extend beyond the tip or end of the deflation tube (or beyond aneedle, prong, or other component used to pierce the balloon shell).These expansion elements each are adapted to contact and engage theinner surface of the intragastric balloon as the retrieval mechanism andthe deflation or aspiration tube is withdrawn from the stomach of thepatient. Typically, each expansion member is capable of taking on afirst profile or dimensions (deployment configuration or profile)smaller than or equal to the inner diameter of the lumen such that itcan pass through the deflation or aspiration tube. When in the open orunrestricted space within the intragastric balloon, the expansionelement expands to a second profile or dimensions (deployed or retrievalconfiguration or profile) substantially greater than the outer diameterof the needle and/or tube.

This larger-sized profile or configuration and the contact surface(s) ofthe expansion element allow the expansion element to effectively contactor “grasp” the inner surface of the balloon adjacent to the hole thatwas previously formed in the balloon shell by the needle or puncturemember of the retrieval mechanism. In some cases, the “grasping”includes trapping or pinching balloon material near the formed holebetween the contact surfaces of the expansion element and the outersurfaces of the needle or puncture member or deflation tube. These andother features of the invention will become clear from the followingdescription of the retrieval systems of the invention and the multipleembodiments of retrieval mechanisms useful in such systems to contactthe inner surface of intragastric balloons so as to grasp or capture theballoons for efficient retrieval from a patient.

FIG. 1 illustrates an inflatable/deflatable object removal system 110 ofthe invention that is particularly well suited for use when the objectis an intragastric balloon. The object removal system 110 includes asingle lumen tubing 120 that is configured with an outer wall 122 thathas a diameter such that the tube 120 is small enough to pass through aworking channel or lumen of an endoscope, gastroscope, or the like (notshown). The tube wall 122 defines a lumen 124 that extends from one tothe other end of the tube 120. At the distal end, a needle or puncturemember 112, such as a hollow cannulated needle with a relatively sharptip 114, is provided, which may be an extension of the tube 120 or aseparate component that is attached to the tube wall 122. The puncturemember 112 optionally has its lumen or hollow center coupled to thelumen 124 or other channel through the tube 120 such that fluid (notshown) can be aspirated from an object or balloon 104 that has its shellor wall 106 pierced by the tip 114 of the member 112.

During deflation operations, the fluid contained by the inner surfaces108 of the balloon wall 106 may be allowed to flow into the stomach orcavity of a patient, but often it is desirable to aspirate or evacuatethe fluid via the tube 120. In this regard, the insertion of the needlemember 112 results in the lumen 124 provided in the tube 120 beingexposed to the interior space of the balloon 104 defined by the innersurface 108 of the balloon wall 106 (e.g., via the needle member 112depending upon how deep the tube 120 is inserted into the balloon 104).To facilitate insertion and later deflation of the balloon 104, aconnector 126 (e.g., a luer connector or the like) is provided with atube connector that is also hollow or has an internal channel 129 at theproximal end of the removal system 110. After the tube 120 is positionedin a patient and the tip 114 has pierced a balloon 104, the connector126 can be connected to a suction mechanism to apply suction andevacuate fluid from the balloon 104 via needle 112 and lumen 124 of tube120. While the system 110 is shown with the single lumen tube 120 and aparticular connector and puncture arrangement, these components can bevaried significantly to practice the invention such as with a dual lumentube, a different connector, and a differing needle or piercing device,with an important feature of the aspirator portion being the ability topierce the wall 106 and position a lumen port, opening, or end withinthe balloon 104 to provide access to the inner surface 108 of the wall106.

A significant feature of the system 110 is the improved ability of thesystem 110 for grasping and retrieving the deflated balloon 104. To thisend, the system 110 includes a retrieval mechanism (which is shown inmore detail in FIGS. 2A-2C). The retrieval mechanism includes adeployment member 132 that may be a wire, a twisted wire rope, aflexible rod, a tube, or other component that is adapted for beingpushed and pulled through the lumen 124 of the tube 120. As shown, theretrieval mechanism includes a handle 138 attached to the proximal endof the member 132 and an expansion element made up of a bar (or T-bar)134 attached with connector 136 (such as a pin, solder or otherconnection). The handle 138 is used by an operator (such as doctor,surgeon, or other medical technician) to push the wire or member 132until the distal end of the wire or member 132 and the bar 134 passesthe tip 114 of the needle 112 and is positioned within the balloon 104.At this point (i.e., the deployed or fully deployed position), theexpansion element is able to expand or convert from a first, smallerprofile or configuration to a second, larger profile or configuration(e.g., a first profile with dimensions that allow the bar and wire 134and 132 to fit within the lumen 124 and a second profile with dimensionsthat are larger than the tip 114 used to pierce the balloon wall 106).Because the expansion or conversion element is an important feature ofthe invention and system 110, the following figures and discussionemphasize a number of embodiments of retrieval mechanisms with varyingexpansion or conversion elements, with the tube 120 and other featuresof the system 110 being useful in combination with any of the retrievalmechanisms (and, as discussed earlier, the retrieval mechanisms beinguseful with removal systems other than that shown in FIG. 1).

FIGS. 2A-2C illustrate one embodiment of a retrieval mechanism 230 thatmay be used in a removal system, such as system 110 of FIG. 1. As shown,a deflation or aspiration tube 220 with a wall 222 defines a lumen 224(such as a lumen with a circular or other shaped cross section). At theend of the tube 220 is a puncture or needle member 212 that is affixedto the tube wall 222 such as by threading and/or adhesive or the like.The tubing 220 and member 212 may be made of a number of materials topractice the invention such as flexible plastic or elastomer, e.g.,PTFE, ETFE, or PDVF. With its outer dimensions being selected to be lessthan the inner diameter of an endoscope working channel, such as lessthan about 0.1 inches, this results in a lumen outer diameter less thanthis dimension, such as 0.08 inches, 0.05 inches, or less. The deployingor first profile or configuration of the retrieval mechanism 230 isselected to be less than the diameter of the lumen to allow itsdeployment into the balloon interior. Clearly, the specific dimensionsare not limiting with the more important aspect being the relativedimensions.

The puncture member 212 is shown after it has been used to pierce theballoon 104 by making a hole in the wall 106. As shown, the outlet ortip 216 of the member 212 is within the balloon 104 such that the lumenor channel 214 of the member 212 is within the balloon 104. In FIG. 2A,the retrieval mechanism 230 is being deployed as shown at arrow 231through the lumen 224 into the interior of the balloon 104. Theretrieval mechanism 230 includes a deployment member 232 (e.g., a wire,wire rope, flexible rod, or the like made of metal or other materials),which is connected to a handle (not shown). An expansion element 225 isattached with connector 226 to the end of the deployment member 232. Theexpansion element 225 can be thought of as a T-bar and includes anelongate body of a width, W, with two opposing ends 228, 229 (showncurved in this embodiment but may take other shapes to practice theinvention). The width, W, of the expansion element 225 is less than thelumen 224 and channel 214 in the puncture member 212. As shown, theexpansion element 225 is collapsible onto the wire or deployment member232 while it is being deployed through the lumen 224 of the tube 220. Inother words, the bar or body of the expansion element 225 may be alignedwith the wire 232 to fit into the tubing 220, and when emerging from thetubing 220 end 212 resumes a perpendicular orientation.

FIG. 2B illustrates the expansion element 225 in its deployed profile orconfiguration in which its body is perpendicular to (or at least nolonger aligned with) wire 232. The expansion element 225 swings down asshown with arrow 240 to the deployed or second larger profile. Thelarger or second profile results in the body or expansion element 225having a length, L, that is larger than the outer diameter of thepuncture element 212, and the length, L, is typically significantlylarger than this diameter (e.g., 2 to 6 or more times larger than thisdiameter) with the upper limitation being that the length of theextension element 225 as measured along the elongate body from end 228to end 229 is less than the inner diameter of the channel through whichthe tube 220 and balloon 104 be removed, e.g., less than a patient'sesophagus inner diameter such as less than about 0.75 inches). With thisprofile, the element 225 is longer than the hole formed in the balloonwall 104.

As shown, the extension element 225 has a contact or grasping surface227. When the retrieval mechanism 230 is withdrawn or pulled back towardthe tube 220 as shown at arrow 242, the contact surface 227 of theexpansion element 225 contacts (engages or grasps) the inner surface 108of the balloon wall 106. This grasping or contact by the expansionelement 225 is shown in FIG. 2C. As shown, once the wire or deploymentmember 232 is pulled or withdrawn until the contact surface 227 abutsthe tip or end 216 of the puncture member 212 (or pinches balloon wall106), the tube 220 of the removal system is pulled or withdrawn as shownat arrows 246 to remove the balloon 104 along with the tube 220 andretrieval mechanism 230. The expansion element 225 is effective forgrasping the balloon 104 by contacting the inner surface 108, and theballoon shell 106 can be pulled out of its environment (e.g., a stomachor other patient cavity) draped over the T-bar or elongate body of theexpansion element 225.

FIGS. 3A to 3C illustrate another embodiment of a retrieval mechanism330 being deployed into a balloon 104 that has been pierced by tube 220and puncture member 212 (with similar components shown in FIGS. 2A to 2Cnot being described in detail). The mechanism 330 can be thought of asusing a balloon grasper to grasp the inner surface 108 of the balloonwall 106. Specifically, the retrieval mechanism 330 includes a tube ofsmaller diameter than the tube 220, and this tube is advanced as shownin FIG. 3A at arrow 331 through the lumen 224. At the end of the tube332, a small balloon or inflatable expansion element 336 is provided inthe lumen 334 of smaller tube 332. The expansion element 336 is attachedat or near the end 338 of the tube 332.

As shown in FIG. 3B, the expansion element 336 includes a wall or shell337 and an inner surface 339. When the expansion element 336 (or end 338of tube 332) is positioned within the balloon 104 (or past the hole inwall 106), air or other fluid 344 is forced through the lumen 334 oftube (or deployment member) 332 to force the element 336 out of the tube332 and to apply pressure against inner surface 339 of wall 337 andinflate the expansion element 336 as shown with arrows 348. Theinflation of element 336 may be controlled by achieving a predeterminedpressure in the lumen 334 and element 336 or by inserting apredetermined volume of gas or fluid 344. At FIG. 3C, the expansionelement 336 is shown inflated to a second configuration or profile andan outer diameter, D, that is greater than the outer diameter of thepuncture member 212 (and hole in wall 106), e.g., 10 times larger or thelike. The outer surfaces of the wall 337 (e.g., contact surfaces of theexpansion element 336) abut or engage the inner surface 108 of theballoon wall 106 when the tube 332 is withdrawn into the deployment tube220 until the expansion element 336 hits or is adjacent to the tip 216of the puncture member 212. The tube 220 can then be withdrawn to removethe deflated intragastric balloon 104 with the balloon shell 106 drapedover the expansion element 336. Again the diameter, D, is selected to belarger than the outer diameter of the member 212 and smaller than thechannel through which the tube 220 is removed from a patient's body,such as less than about 0.75 inches when the channel is a patient'sesophagus. The wall 337 of the expansion element 336 may be formed frommany elastic materials such as rubber or the like, and in some cases,the contact surface or outer surface of wall 337 is rough (or roughened)to improve the “grasping” of inner surface 108 of balloon 104.

FIGS. 4A and 4B illustrate another embodiment of a retrieval mechanism430 that includes an expansion element that can be thought of as a“folding anchor.” FIG. 4A illustrates the expansion element in the firstor deploying profile or configuration in which it has dimensions thatare less than or equal to the inner diameter of the lumen 224 of tube220. The expansion element includes a connector 434 attached to the endof deploying member 433. The connector 434 may be a circular disk orplate that and the member 433 may be a wire, a wire rope, or otherflexible component. The expansion element further includes a number ofanchor legs 432 (such as 3 or more) that are elongate bodies with twoends 436, 439 and a contact surface 438.

FIG. 4B illustrates how the legs 432 expand out or unfold/deploy whenthe expansion element is positioned beyond the tip 216 of puncturemember 212 within the interior volume of the balloon 104 defined byshell 106. To this end, the legs are pivotally attached at ends 439 tothe connector 434. In some embodiments, the legs and connector areformed such that the deployed or second profile shown in FIG. 4B is an“at rest” configuration (such as by forming the anchor expansion elementas a single piece) and the unfolding is the result of the legs returningto their at rest position. As shown, though, the legs “fall” or pivotfrom their first configuration shown in FIG. 4A proximate to thedeployment member 433 to the deployed or expanded, second configurationshown in FIG. 4B. In the fully deployed position of FIG. 4B, theexpansion element of retrieval mechanism 430 has a “diameter” (orwidth), D, that is measured from the outer tip 436 of one leg 432 to anouter tip of an opposing leg. This diameter, D, again is significantlylarger than the outer diameter of the tube 220 and/or puncture member212 (e.g., such as 2 to 10 times or more larger) and less than apredetermined maximum value to allow removal from a patient. Then, asshown at arrow 450, the deployment member 433 is pulled back into thetube lumen 224 until the contact surface 438 of the legs 432 contactsthe inner surface 108 of the balloon wall 106 when the connector abutsor is proximate to the tip 216 of member 212. Then, the tube 220 anddeployment member 433 are withdrawn or pulled from the patient toretrieve the deflated balloon 104.

FIGS. 5A and 5B illustrate yet another retrieval mechanism 530 useful inobject removal systems of the invention. With this retrieval mechanism530, the aspirator tube 220 is again placed within the hollow shape orshell 106 of the object or balloon 104. The retrieval mechanism 530 isthen advanced down the lumen 224 into the balloon 104. The retrievalmechanism 530 includes a deployment member (e.g., a wire or the like)534 that is connected at a first end 538 to an expansion element 536.The other distal end 539 of the expansion element 536 is fed into theballoon 104. This embodiment of the retrieval mechanism 530 can bethought of as a “spring” embodiment as the expansion element 536 may bemade up of a length of spring, a spring coil, spring wire, or the likethat can be “straightened” into a first profile or configuration forfeeding through the tube lumen 224 and then, when in an unrestrictedspace such as the interior space of the balloon shell 106, the expansionelement spring 536 returns to its at rest or second profile orconfiguration.

The unrestricted or at rest configuration of the expansion element 536can be defined as having an outer dimension, D (even if not a truecircle or sphere) that is larger than the outer diameter of the puncturemember 212 and/or tube 220 as shown in FIG. 5B (e.g., 2 to 10 or moretimes larger). As shown at arrow 550, the wire or deployment member 534is withdrawn or pulled back up the lumen 224 of the tube 220 until thefirst or proximal end 538 of the expansion element 536 contacts or ispulled within the lumen 214 of the puncture member 212. At this point,the unrestricted spring, which has resumed its natural or at rest stateof a coil, spiral, or other non-linear shape, may compress somewhat butis selected to have a stiffness (or resistance to leaving its at reststate) that allows it to contact the inner surface 108 of the balloonwall 106 and grasp the balloon 104. In other words, the expansionelement 536 shown in FIG. 5B is selected such that forces applied by thedeflated balloon inner surface 108 (“retraction forces”) do not compressthe element 536 to a point where its dimension, D, is less than theouter diameter of the member 212. As a result, the expansion element 536is able to “grasp” or engage the inner surfaces 108 when the tube 220 iswithdrawn from the hole in the wall 104, and the balloon shell 106 canbe pulled out of its environment draped over the spring element 536.

FIGS. 6A and 6B show another retrieval mechanism 630 with a “tab-based”expansion element. As shown by arrow 631, the tab expansion element isfed through the lumen 224 of the aspiration tube 220 with wire ordeployment member 632. The member 632 is attached to the body 634 of theexpansion element, and the body 634 can be aligned with the member 632in a first, smaller profile or configuration of the expansion element.The elongated body 634 may be a relatively stiff or rigid tube or wire.On each opposite end of the body 634 is attached a tab or graspingmember 638, 639. Each of these tabs 638, 639 may have a variety ofshapes and be made of a variety of materials to practice the invention.As shown, the tabs 638, 639 are relatively planar and have a circularshape. In other cases, the tabs 638, 639 may be more spherical orhemispherical in shape or range toward planar but with a different shapesuch as square, rectangular, triangular, hyperbolic, or the like. Thematerials used for the body 634 and tabs 638, 639 may be the same (suchas when these components are stamped out or formed as a unitary piece),may be selected for easy joining (such as soldering or the like), or maybe different.

As shown in FIG. 6B, body 634 of the expansion element “expands” byswinging out of alignment with the wire 632, such as to a perpendicularor transverse position relative to the wire 632. This expanded orsecond, larger profile or configuration of the expansion element resultsin the expansion element having a dimension or width, D, that is largerthan the outer diameter of the puncture element 212 and tube wall 222(e.g., 2 to 8 time or more larger with the ratio of 5:1 being used insome embodiments). When the wire 632 is withdrawn into the lumen 224, asurface of the body 632 proximate to the wire 632 contacts the tip orend 216 of the puncture member 212. In this illustrated position, thetabs 638, 639 extend outward from the puncture member 212. When, asshown by arrow 652, the tube 220 and retrieval mechanism 630 arewithdrawn, contact surfaces of the tabs 638, 639 contact or “grasp” theinner surfaces of the balloon shell 106. The contact surfaces of eachtab 638, 639 are typically about the size of or less than the innerdiameter of the tube lumen 224 or lumen 214 of the puncture element 212,whichever is less, to allow the tabs 638, 639 to be passed through thetube 220 and member 212 into the balloon 104. The balloon shell 104 canthen be pulled out of its environment draped over the shaped extensions638, 639 of the expansion element of the retrieval mechanism 630.

FIGS. 7A and 7B illustrate still another retrieval mechanism 730 usefulwith object removal systems of the invention. As shown, the expansionelement 733 of the retrieval mechanism 730 can be though of as anexpandable tube retriever or grasper. To this end, the retrievalmechanism 730 includes a hollow tube 732 of flexible plastic orelastomeric materials with an outer diameter less than the innerdiameters of aspiration tube 220 and puncture member 212. The tube 732can be passed or advanced as shown at arrow 731 in a deflated balloon104. The tip or expansion element 733 includes a number of cut slitsparallel to the axis of the tube 732, e.g., 4 slits spaced about 90degrees apart about the circumference of the tip 733. The retrievalmechanism 730 further includes a wire 735 that is attached toward thedistal end of the tip 733 such as to a plate 736 at or near the distalend of tip 733. When the expansion element or tip 733 is positionedwithin the shell 106 of the balloon 104, tension is applied as shown atarrow 750 to the wire or string 735 such that the attached end of thetip or plate 736 is pulled with the wire 735 toward the tube 220 orpuncture member 212. This movement causes the expansion element 733 withthe slits 734 to buckle and expand from the first small profile to asecond profile (e.g., a cruciform shape or the like) with a width, W,that is larger than the outer diameter of the puncture member 212 andtube wall 222 (e.g., 2 to 5 or more times larger with a minimum ratio of3.5:1 being used in some cases). The outer surfaces of the expansionelement 733 then provide contact surfaces that contact the inner surface108 of the balloon wall 106 when the retrieval mechanism 730 is pulledby wire 735 such that the expanded tip 733 abuts the puncture element212 and the tube 220 is withdrawn as shown at 752.

FIGS. 8A to 8D illustrate a retrieval mechanism 830 that makes use of afunnel expansion element 834. The retrieval mechanism 830 includes afeed or deployment wire 832 that is used to deploy as shown at arrow 831the expansion element 834, which is attached to the wire 832, throughthe lumen 224 of the aspiration tube 220. As shown by arrows 842 in FIG.8B, the funnel expansion element 834 expands outward from its firstprofile that is smaller than the inner diameter of the tube 220 andpuncture member 212 to its second profile with a width (or diameter), W,that is larger than the outer dimensions of the tube 220 and member 212.The expansion element 834 may include a circular plate 835 that isattached to the wire 832 and an expandable/retractable wall 836. Thewall 836 may take a number of forms, and in one embodiment, is made of aplurality of vanes or ribs (such as elongate metal plates) that arewrapped about the wire 832. In this case, the wall 836 expands outwardto width, W, and exposes interior surfaces 838 of the wall 836.

As shown by arrow 852 in FIG. 8C, the tube 220 is withdrawn from theballoon such that the wire 832 of the retrieval mechanism 830 extendsthrough the hole 856 in the balloon wall 106 and the expansion element834 remains in the balloon 104 (e.g., the tube 220 is withdrawninitially without withdrawing or tensioning the wire 832). Then, asshown by arrow 862 in FIG. 8D, tension is applied to the wire 832 of theretrieval mechanism 830 such that the funnel expansion element 834 movestoward the puncture member 212 and tube 220. The inner surface 108 ofthe balloon wall 106 is contacted by the upper edge of the wall 836 suchthat a portion of the balloon wall 106 is pinched or sandwiched betweenthe inner surface 838 of the wall 836 of the expansion element 834 andthe outer surfaces of the puncture member 212 and/or tube wall 222.Preferably, to support this grasping action, the shape of the wall 836in the expanded or second configuration is selected to correspond to theconical shape of the exterior surfaces of the tip or puncture member 212or end of tubing 220. When retracted, the balloon wall 106 is capturedbetween the funnel expansion element 834 and the cone tip 212 with someforce. The balloon shell 104 can then be pulled out of its environmentby applying tension to the tube 220 and the wire 832 of the retrievalmechanism 830.

Although the invention has been described and illustrated with a certaindegree of particularity, it is understood that the present disclosurehas been made only by way of example, and that numerous changes in thecombination and arrangement of parts can be resorted to by those skilledin the art without departing from the spirit and scope of the invention,as hereinafter claimed. For example, the body or bar 225 shown in FIGS.2A to 2C may include a groove along one side for receiving the wire 232when the expansion element is placed in the first profile for deployingthrough the aspiration tube. In other embodiments, the T-bar 225 can beattached by a loop at the end of the wire rather than being attached tothe end of the wire 232. In the retrieval mechanism 430 of FIGS. 4A and4B, the anchor legs 432 may have a curved (or concave) shape to increasetheir strength and the outer ends or tips 436 may be textured or includesmall prongs or the like for enhanced grabbing of the inner surface 108of the balloon wall 106. Further, the tube expansion element 733 ofFIGS. 7A and 7B can be “locked” in the expanded position, such as, forexample, by providing a slot or recessed latching surface in the innerlumen walls of the tube 732. A bead or ball or other shape may beattached to the wire 735 within the tip 733 (such as proximal to theplate 736). When the bead or ball is pulled to the slot or recessedlatching surface within the tip 733, the expansion element 733 becomeslatched or locked in the cruciform or expanded profile.

1. A method for evacuating and removing a fluid-filled object positionedin a body cavity of a patient, comprising: positioning an aspiratordevice in the body cavity; piercing a wall of the fluid-filled objectwith the aspirator device, wherein the aspirator device comprises a tubewith a lumen; sliding a retrieval mechanism in the lumen of theaspirator tube, wherein the retrieval mechanism comprises an expansionelement having a deployed configuration greater in size than an outerdiameter of the aspirator tube and wherein the sliding comprisesextending the expansion element at least partially out of the lumen andinto the pierced object; expanding the expansion element to the deployedconfiguration; and withdrawing the retrieval mechanism and the aspiratordevice from the body cavity, wherein during the withdrawing theexpansion element contacts an inner surface of the object wall forcingthe object to be removed from the body cavity with the retrievalmechanism.
 2. The method of claim 1, wherein the retrieval mechanismcomprises a flexible deployment member attached to the expansionelement, and the method further comprises prior to the withdrawing,applying tension on the deployment member to force the expansion memberto abut a tip fixed on the aspirator tube.
 3. The method of claim 2,wherein the applying of the tension results in the expanding of theexpansion element to the deployed configuration.
 4. The method of claim2, wherein the applying of the tension causes the expansion element tocontact the inner surface of the object wall and to sandwich a portionof the wall between the expansion element and the tip of the aspiratortube.
 5. The method of claim 1, wherein the expansion element isselected from the group consisting of a T-bar, an object inflated in theexpanding of the expansion element, a folding anchor device that unfoldsto the deployed configuration, a spring element that returns to anat-rest position during the expanding of the expansion element, anelongate body with tabs attached at opposite ends, a tubular body withslits cut in a spaced-apart manner, parallel to a longitudinal axis ofthe tubular body and with a tensioning wire attached to an end oftubular body, and a funnel collapsible into a cylinder and expandableinto a frustaconical shape in the deployed configuration.